Combination therapy with glatiramer acetate and mitoxantrone for the treatment of multiple schlerosis

Inactive Publication Date: 2007-07-26
TEVA PHARMA IND LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Benefits of technology

[0017] The subject invention further provides a pharmaceutical composition comprising an amount of glatiramer acetate and an amount of

Problems solved by technology

The administration of two drugs to treat a given condition, such as a form of multiple sclerosis, raises a number of potential problems.
Thus, when two drugs are administered to treat the same condition, it is unpredictable whether each will complement, have no effect on, or interfere with, the therapeutic activity of the other in a human subject.
Not only may the interaction between two drugs affect the intended therapeutic activity of each drug, but the interaction may increase the levels o

Method used

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  • Combination therapy with glatiramer acetate and mitoxantrone for the treatment of multiple schlerosis

Examples

Experimental program
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Example

EXAMPLE 1

Clinical Trial of Multiple Sclerosis

[0067] The primary objective of the trial is to determine whether short-term immunosuppression with mitoxantrone (Novantrone®) followed by chronic treatment with Glatiramer Acetate (Copaxone®) in comparison to treatment with Copaxone® for the same period of time without immunosuppression by mitoxantrone (Novantrone®) is well-tolerated and safe in patients with relapsing forms of MS as determined by clinical, laboratory and magnetic resonance imaging (MRI) parameters. The primary endpoints are tolerability and safety as measured by laboratory assessments and incidence of adverse experience. The secondary objective is to determine whether short-term immunosuppression with Novantrone® as an induction therapy accelerates the onset and enhances the efficacy of Copaxone® treatment in patients with relapsing forms of MS in 15 months of treatment based on MRI and clinical assessment.

[0068] The design of this trial is a multi-centered, randomiz...

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Abstract

The subject invention provides a method of treating a subject afflicted with a form of multiple sclerosis comprising periodically administering to the subject an amount of glatiramer acetate and an amount of mitoxantrone, wherein the amounts when taken together are effective to alleviate a symptom of the form of multiple sclerosis in the subject so as to thereby treat the subject. The subject invention also provides a package comprising glatiramer acetate, mitoxantrone and instructions for use of the together to alleviate a symptom of a form of multiple sclerosis in a subject. Additionally, the subject invention provides a pharmaceutical composition comprising an amount of glatiramer acetate and an amount of mitoxantrone, wherein the amounts when taken together are effective to alleviate a symptom of a form of multiple sclerosis in a subject. The subject invention further provides a pharmaceutical combination comprising separate dosage forms of an amount of glatiramer acetate and an amount of mitoxantrone, which combination is useful to alleviate a symptom of a form of multiple sclerosis in a subject.

Description

FIELD OF THE INVENTION [0001] The subject invention relates to combination therapy for treating multiple sclerosis. BACKGROUND OF THE INVENTION [0002] One of the more common neurologic diseases in human adults is multiple sclerosis. This condition is a chronic, inflammatory CNS disease characterized pathologically by demyelination. There are five main forms of multiple sclerosis: 1) benign multiple sclerosis; 2) relapsing-remitting multiple sclerosis (RR-MS); 3) secondary progressive multiple sclerosis (SP-MS); 4) primary progressive multiple sclerosis (PP-MS); and 5) progressive-relapsing multiple sclerosis (PR-MS). Benign multiple sclerosis is characterized by 1-2 exacerbations with complete recovery, no lasting disability and no disease progression for 10-15 years after the initial onset. Benign multiple sclerosis may, however, progress into other forms of multiple sclerosis. Patients suffering from RR-MS experience sporadic exacerbations or relapses, as well as periods of remiss...

Claims

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Application Information

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IPC IPC(8): A61K38/16A61KA61K38/00
CPCA61K31/137A61K38/02A61K38/16A61K2300/00A61P25/00A61P25/28
Inventor VOLLMER, TIMOTHY
Owner TEVA PHARMA IND LTD
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